TIAGABINE HYDROCHLORIDE tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

tiagabine hydrochloride (UNII: DQH6T6D8OY) (tiagabine - UNII:Z80I64HMNP)

Pieejams no:

Wilshire Pharmaceuticals, Inc.

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Tiagabine hydrochloride tablets are indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures. Tiagabine hydrochloride tablets are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. The abuse and dependence potential of tiagabine hydrochloride have not been evaluated in human studies.

Produktu pārskats:

Tiagabine hydrochloride tablets are available in four dosage strengths. Store tablets between 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

Wilshire Pharmaceuticals, Inc.
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MEDICATION GUIDE
Tiagabine Hydrochloride Tablets
(tye-AG-a-been HYE-droe-KLOR-ide)
Read this Medication Guide before you start taking tiagabine
hydrochloride tablets and each time you get
a refill. There may be new information. This information does not take
the place of talking to your
healthcare provider about your medical condition or treatment.
What is the most important information I should know about tiagabine
hydrochloride tablets?
Do not stop taking tiagabine hydrochloride tablets without first
talking to your healthcare provider.
Stopping tiagabine hydrochloride tablets suddenly can cause serious
problems.
Tiagabine hydrochloride tablets can cause serious side effects,
including:
1.
Tiagabine hydrochloride tablets may cause seizures in people who do
not have epilepsy. If you do
not have a seizure disorder and you take tiagabine hydrochloride
tablets, you may have a seizure or
seizures that do not stop (status epilepticus). Call your healthcare
provider right away if you have a
seizure and you are not taking tiagabine hydrochloride tablets for
epilepsy.
2.
Like other antiepileptic drugs, tiagabine hydrochloride tablets may
cause suicidal thoughts or
actions in a very small number of people, about 1 in 500. Call a
healthcare provider right away if
you have any of these symptoms, especially if they are new, worse, or
worry you:
•
thoughts about suicide or dying
•
attempts to commit suicide
•
new or worse depression
•
new or worse anxiety
•
feeling agitated or restless
•
panic attacks
•
trouble sleeping (insomnia)
•
new or worse irritability
•
acting aggressive, being angry, or violent
•
acting on dangerous impulses
•
an extreme increase in activity and talking
(mania)
•
other unusual changes in behavior or mood
Suicidal thoughts or actions can be caused by things other than
medicines. If you have suicidal thoughts
or actions, your healthcare provider may check for other causes.
How can I watch for early symptoms of suicidal thoughts and actio

Produkta apraksts

TIAGABINE HYDROCHLORIDE- TIAGABINE HYDROCHLORIDE TABLET
WILSHIRE PHARMACEUTICALS, INC.
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TIAGABINE HYDROCHLORIDE TABLETS
RX ONLY
DESCRIPTION
Tiagabine hydrochloride tablets are an antiepilepsy drug available as
2 mg, 4 mg, 12 mg, and 16 mg
tablets for oral administration. Its chemical name is
(-)-(R)-1-[4,4-Bis(3-methyl-2-thienyl)-3-
butenyl]nipecotic acid hydrochloride, its molecular formula is C
H NO S HCl, and its molecular
weight is 412.0. Tiagabine hydrochloride is a white to off-white,
odorless, crystalline powder. It is
insoluble in heptane, sparingly soluble in water, and soluble in
aqueous base. The structural formula is:
INACTIVE INGREDIENTS
Tiagabine hydrochloride tablets contain the following inactive
ingredients: Anhydrous lactose,
microcrystalline cellulose, pregelatinized starch, crospovidone,
polyethylene glycol 6000, butylated
hydroxyanisole, propyl gallate, colloidal silicon dioxide, magnesium
stearate, stearic acid,
hydroxypropyl cellulose, hypromellose and titanium dioxide.
In addition, individual tablets contain:
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
The precise mechanism by which tiagabine exerts its antiseizure effect
is unknown, although it is
believed to be related to its ability, documented in _in vitro_
experiments, to enhance the activity of gamma
aminobutyric acid (GABA), the major inhibitory neurotransmitter in the
central nervous system. These
experiments have shown that tiagabine binds to recognition sites
associated with the GABA uptake
20
25
2
2
2 mg tablets: FD&C Yellow No. 6.
4 mg tablets: D&C Yellow No. 10.
12 mg tablets: D&C Yellow No. 10 and FD&C Blue No. 1.
16 mg tablets: FD&C Blue No. 2.
carrier. It is thought that, by this action, tiagabine blocks GABA
uptake into presynaptic neurons,
permitting more GABA to be available for receptor binding on the
surfaces of post-synaptic cells.
Inhibition of GABA uptake has been shown for synaptosomes, neuronal
cell cultures, and glial cell
cultures. In rat-derived hippocampal slices, tiagabine has been shown
to prolong GA